Clinical Research Manager

Direct message the job poster from TargetCancer Foundation TargetCancer Foundation is a patient-founded non‑profit organization based in Cambridge, MA that is dedicated to rare cancer research and patient support. TargetCancer Foundation directly supports initiatives at the forefront of rare cancer treatment by funding innovative research, developing patient‑centric clinical studies, and by supporting patients and raising awareness for rare cancers publicly. TargetCancer Foundation (TCF) is seeking a Clinical Research Manager to join the study team for TCF- 001 TRACK (Target Rare Cancer Knowledge) and potential future studies. TCF-001 TRACK is an IRB‑approved clinical trial (NCT04504604) recruiting 400 patients to study precision medicine in rare cancers. TRACK is a fully remote, decentralized trial which provides enrolled patients with genomic testing of tissue and blood, as well as treatment recommendations from a Virtual Molecular Tumor Board. The TRACK study website can be viewed at targetcancer.org/track. Position Overview We are seeking an organized and detail‑oriented Clinical Research Manager (CRM) to manage and coordinate the TRACK clinical trial, as well as future TargetCancer Foundation decentralized clinical trials. The CRM will work closely with the TargetCancer Foundation study team, the principal investigators (PIs), study participants, and others to ensure the successful execution of trials utilizing innovative, patient‑centric approaches such as eConsent, remote monitoring, and digital platforms. This position requires the highest attention to detail, excellent communication and project management skills, technological aptitude, and a willingness to think creatively and innovatively in all elements of study execution and management. The CRM will also have the opportunity to assist in the development and operational design of future TargetCancer Foundation clinical studies. Key Responsibilities Trial Operations Connect with medical institutions to collect medical records of enrolled patients, and secure continuous updates to records throughout the period of the study. Support coordination of the transfer of enrolled patient tissue from treating institutions to the molecular testing partner. Coordinate mobile phlebotomy visits for enrolled patients, and distribute related blood kits. Support the implementation of decentralized trial protocols, including remote monitoring and data collection into a centralized database. Facilitate weekly Molecular Tumor Board meetings, including distribution of pre‑meeting materials, meeting execution, and post‑meeting follow up and report development. Run weekly study team meeting calls and provide status on enrolled patients. Manage project operations across a multidisciplinary team, including tracking all aspects of the project, identifying needs, and facilitating execution of solutions. Execute on strategic priorities and think innovatively in terms of trial infrastructure, workflow, and design. Data Management Ensure accurate and timely collection of data from PRO. Perform data entry and quality checks in electronic data capture (EDC) systems. Monitor and document protocol deviations. Maintain online study task tracking database through continuous and constant updates. Participant Management Partner with other TRACK team members to coordinate the recruitment, screening, and enrollment of study participants in a decentralized model. Facilitate remote participant engagement through eConsent platforms. Serve as a key point of contact for participants, addressing questions, concerns, and logistical needs. Provide education to participants on study procedures for their ongoing participation in TRACK. Communicate with enrolled patients and provide updates on trial status and movement. Communication and Collaboration Act as a liaison between participants, investigators, and other trial stakeholders. Collaborate with technology vendors and support teams to troubleshoot issues with digital tools and platforms. Provide updates to the study team regarding participant progress, data collection, and trial milestones. Regulatory Compliance Maintain regulatory documents and ensure compliance with Good Clinical Practice (GCP) guidelines and local regulations. Ensure participant privacy and data security, adhering to HIPAA, and other relevant guidelines. Assist with Institutional Review Board (IRB)/Ethics Committee submissions and approvals as needed. Qualifications Education Bachelor’s degree in life sciences, nursing, or a related field, Master’s degree preferred. Certification in clinical research (e.g., ACRP or SOCRA) preferred. Experience 5+ years of experience in clinical research and/or project management in clinical research. Experience with decentralized or hybrid trial models is highly desirable. Experience with unique challenges faced by rare cancer patients preferred. Knowledge Familiarity with FDA regulations for clinical trials, including decentralized trials. Understanding of decentralized trial components, including eConsent. Skills Mission‑driven attitude and creative perspective on enabling patients to get involved in research Excellent communication and interpersonal skills, particularly in virtual environments. Technological aptitude to manage and troubleshoot devices and platforms. Ability to respond to shifting priorities, navigate ambiguity, and demonstrate a high level of initiative and problem‑solving skills. Employment Type Full‑time/Part‑time (Flexible or remote work options available) This role is central to the success of TargetCancer Foundation’s decentralized clinical trials, enabling patient‑centric research while ensuring compliance, data integrity, and participant satisfaction. This is a hybrid position, based at TCF’s Cambridge, MA offices, and allowing for remote work. TargetCancer Foundation is a 501c3 non‑profit organization located in Cambridge, MA and is governed by a Board of Directors. More information is available at TargetCancer Foundation is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law. #J-18808-Ljbffr